# K200446: STERIS Patient Warming System

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Jun 13, 2020 after 110 days
- Product code: DWJ (System, Thermal Regulating)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K991684 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112488: Hotdog Patient Warming System, Augustine Biomedical & Design, LLC (2011) Summary page 5.

## Indications for use
Patient Warming System is a modular, electrically conductive Temperature Management System with adjustable temperature in a pre-defined range. The Patient Warming System is intended to prevent or treat hypothermia and maintain normothermia. The Patient Warming System is intended primarily for use in hospital and surgical centers. The Patient Warming System patient population includes adult and pediatric patients but excludes infant and neonatal patients.

Source page: https://510kreport.com/device/K200446
Methodology: https://510kreport.com/methodology